{"id":7647,"date":"2024-01-10T04:06:33","date_gmt":"2024-01-10T04:06:33","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=7647"},"modified":"2024-01-11T16:50:07","modified_gmt":"2024-01-11T16:50:07","slug":"alignment-of-iso-9001-2015-and-iso-13485-2016","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/alignment-of-iso-9001-2015-and-iso-13485-2016\/","title":{"rendered":"ISO 13485:2016 and ISO 9001:2015:  Are They Aligned?"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7647\" class=\"elementor elementor-7647\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7388bb3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7388bb3\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4264d41\" data-id=\"4264d41\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-d04a716 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"d04a716\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-e193c4d\" data-id=\"e193c4d\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa22ff3 elementor-widget elementor-widget-post-info\" data-id=\"aa22ff3\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/css\/custom-widget-icon-list.min.css?ver=0\"><link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-7f6be35 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2024\/01\/10\/\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\tJanuary 10, 2024\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25cfb2d elementor-widget elementor-widget-heading\" data-id=\"25cfb2d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">FDA QSR vs. QMSR: What Medical Device Manufacturers That DO NOT Have ISO 13485 Need to Know<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78a7c7e elementor-widget elementor-widget-image\" data-id=\"78a7c7e\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"2475\" height=\"1856\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2021\/02\/Regulatory-Compliance-.jpg\" class=\"attachment-full size-full wp-image-3827\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2021\/02\/Regulatory-Compliance-.jpg 2475w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2021\/02\/Regulatory-Compliance--300x225.jpg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2021\/02\/Regulatory-Compliance--1024x768.jpg 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2021\/02\/Regulatory-Compliance--768x576.jpg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2021\/02\/Regulatory-Compliance--1536x1152.jpg 1536w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2021\/02\/Regulatory-Compliance--2048x1536.jpg 2048w\" sizes=\"(max-width: 2475px) 100vw, 2475px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f7a5edb elementor-widget elementor-widget-text-editor\" data-id=\"f7a5edb\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p><strong>Short answer:<\/strong>\u00a0No.<\/p><p><strong>Longer answer:<\/strong>\u00a0From a high-level perspective, the standards now differ in intent, content, and structure.<\/p><h3>\u00a0<\/h3><h3><strong>A high-level look at the alignment between ISO 9001:2015 and ISO 13485:2016<\/strong><\/h3><h4>\u00a0<\/h4><h4><strong>Intent:<\/strong>\u00a0Not fully aligned<\/h4><p>The standards share one ultimate goal: Both ISO 9001:2015 and ISO 13485:2016 specify quality management system (QMS) requirements by which an organization must demonstrate that it can consistently provide products and services that meet customer and statutory\/regulatory requirements.<\/p><p>ISO 9001, however, adds enhancing customer satisfaction and continual improvement as goals. As ISO 13485 has matured, it has moved way beyond ISO 9001. For the 2016 version, one objective of the working group that developed the new standard was to ensure ISO 13485 would better support the global alignment of regulatory requirements for medical devices.<\/p><h4>\u00a0<\/h4><h4><strong>Content:<\/strong>\u00a0Not fully aligned<\/h4><p>ISO 9001 specifies requirements that are generic so that any organization, regardless of the products or services it provides, can use the standard. ISO 13485 specifies requirements for organizations involved in one or more stages of the medical device life cycle. To a large extent, ISO 13485 keeps the fundamentals of quality management systems we see in ISO 9001, adding or subtracting, where appropriate, requirements that are\/are not relevant to medical devices.<\/p><p>There are also more definitions in ISO 13485, which makes sense when you consider that ISO 13485 serves a distinct, high-risk industry: medical devices.<\/p><h4>\u00a0<\/h4><h4><strong>Structure:<\/strong>\u00a0Somewhat aligned<\/h4><p>While ISO 13485:2016 maintains the same structure of its prior version (based on ISO 9001:2008), the new structure of ISO 9001:2015 has an entirely fresh look and feel.<\/p><p>ISO 9001:2015 is based on Annex SL, which is intended to provide a uniform frame for writers to use when developing or revising standards. One goal of Annex SL is to support consistency in the writing of standards to make it easier to integrate multiple systems (e.g., quality, environmental, or safety).<\/p><p>The 2016 edition of 13485 does not follow the Annex SL structure, but it is possible that future editions of ISO 13485 may do so.<\/p><p>\u00a0<\/p><p>Below, a visual comparison between the two structures:<\/p><p>\u00a0<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-45 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2017\/06\/5_ISO_align_osam1.png\" alt=\"\" width=\"680\" height=\"570\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2017\/06\/5_ISO_align_osam1.png 680w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2017\/06\/5_ISO_align_osam1-300x251.png 300w\" sizes=\"(max-width: 680px) 100vw, 680px\" \/><\/p><p>We maintain that ISO 9001:2015 and ISO 13485:2016 are not as aligned as you may have heard. Organizations holding certifications to both standards need to identify and address these differences as they upgrade to the most current versions of the standards.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a24cfc2 elementor-widget elementor-widget-heading\" data-id=\"a24cfc2\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Your Next Step<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-91e0879 elementor-widget elementor-widget-text-editor\" data-id=\"91e0879\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Oriel STAT A MATRIX is available to assist organizations of all sizes in addressing the risk requirements, needed documentation, and regulatory compliance necessary for transitioning to ISO 13485:2016.<\/p><p>Interested in learning more about ISO 13485\u2032 Consider our\u00a0<a href=\"https:\/\/www.orielstat.com\/courses\/FDA-QSR-training-21cfr820\">ISO 13485 and FDA\u2019s Fundamentals<\/a>\u00a0training class \u2013 choose from virtual instructor-led or in person deliveries.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5f65133 elementor-widget elementor-widget-text-editor\" data-id=\"5f65133\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\tHere are the most significant changes that manufacturers need to be aware of:\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-735f048 elementor-widget elementor-widget-text-editor\" data-id=\"735f048\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\tYou can see which terms are being carried into the QMSR in section <a href=\"https:\/\/www.federalregister.gov\/documents\/2022\/02\/23\/2022-03227\/medical-devices-quality-system-regulation-amendments#sectno-reference-820.3\" target=\"_blank\" rel=\"nofollow\" noindex=\"noindex\">820.3<\/a> of the proposed QMSR.\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a3400fd elementor-widget elementor-widget-shortcode\" data-id=\"a3400fd\" data-element_type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-shortcode\"><div class=\"container\">\n    <div class=\"col-lg-12 col-md-12\">\n        <h5 class=\"elementor-heading-title elementor-size-default\">Our team is here to help. <a href=\"javascript:void(0);\" rel=\"nofollow\" noindex=\"noindex\">Contact us online<\/a><\/h5>\n        <h5 class=\"elementor-heading-title elementor-size-default\">or<\/h5>\n        <h6 class=\"elementor-heading-title elementor-size-default\">Get answers right now. Call<\/h6>\n    <\/div>\n    <div id=\"Bottom_icons1_DivOfficePhone\" class=\"row new_update_add\">\n<div class=\"col-lg-6 col-md-12 borderbottom\">\n <div class=\"block-text1\">\n     <img decoding=\"async\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/11\/us-flag.jpg\">\n     <p>\n         <b>US Office<\/b>Washington DC<\/p>\n <\/div>\n <p>\n     <a href=\"tel:1.800.472.6477\">1.800.472.6477<\/a><\/p>\n<\/div>\n<div class=\"col-lg-6 col-md-12\">\n <div class=\"block-text1\">\n     <p>\n         <b>EU Office<\/b>Cork, Ireland<\/p>\n     <img decoding=\"async\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/11\/eu-flag.jpg\" class=\"img-right-sec\">\n <\/div>\n <p>\n     <a href=\"tel:+353 21 212 8530\">+353 21 212 8530<\/a><\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-d2b128c\" data-id=\"d2b128c\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3de1869 elementor-widget elementor-widget-sidebar\" data-id=\"3de1869\" data-element_type=\"widget\" data-widget_type=\"sidebar.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<section id=\"search-2\" class=\"widget widget_search\"><form role=\"search\" method=\"get\" class=\"search-form\" action=\"https:\/\/www.orielstat.com\/blog\/\">\n\t\t\t\t<label>\n\t\t\t\t\t<span class=\"screen-reader-text\">Search for:<\/span>\n\t\t\t\t\t<input type=\"search\" class=\"search-field\" placeholder=\"Search &hellip;\" value=\"\" name=\"s\" \/>\n\t\t\t\t<\/label>\n\t\t\t\t<input type=\"submit\" class=\"search-submit\" value=\"Search\" \/>\n\t\t\t<\/form><\/section><section id=\"block-2\" class=\"widget widget_block\">\n<figure class=\"wp-block-image size-large\"><a href=\"#mailmunch-pop-545876\"><img decoding=\"async\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2017\/06\/Blog-subscribe.jpg\" alt=\"\"><\/a><\/figure><\/section><section id=\"categories-3\" class=\"widget widget_categories\"><h2 class=\"widget-title\">Search by Topic<\/h2>\n\t\t\t<ul>\n\t\t\t\t\t<li class=\"cat-item cat-item-12\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/all-medical-device-ra-qa\/\">All Category<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-74\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/ai\/\">Artificial Intelligence (AI)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-64\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/auditing\/\">Auditing<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-71\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/capa\/\">CAPA<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-20\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/capa-for-medical-devicecompliance\/\">CAPA and Root Cause Analysis<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-27\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/clinical-evaluation-reports\/\">Clinical Evaluation Reports<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-59\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/combination-products\/\">Combination Products<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-23\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/complaint-handling-postmarket-surveillance\/\">Complaint Handling and PMS<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-33\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/design-control\/\">Design Control<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-34\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/in-vitro-diagnostics-ivdr\/\">EU IVDR (2017\/746)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-16\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/eu-medical-device-regulation\/\">EU MDR (2017\/745)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-14\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/us-fda-qsr\/\">FDA 21 CFR Part 820<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-21\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/510k-submissions\/\">FDA 510(k) Submissions<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-69\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/fda-eua\/\">FDA EUA<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-4\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/iso-134852016\/\">ISO 13485 QMS Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-30\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/risk-management-iso14971\/\">ISO 14971 Risk Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-40\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/laboratory-developed-tests-ldt\/\">Lab Developed Tests<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-66\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/labeling\/\">Labeling<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-18\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/mdsap\/\">MDSAP<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-58\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/pharmaceutical\/\">Pharmaceuticals<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-28\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qms-auditing\/\">QMS Auditing<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-72\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qmsr\/\">QMSR<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-73\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/regulatory-compliance\/\">Regulatory Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-65\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software\/\">Software<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-63\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software-cybersecurity\/\">Software and Cybersecurity<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-32\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/supplier-management\/\">Supplier Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-67\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/training\/\">Training<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-1\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/medical-device-ra-qa\/\">Uncategorized<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-35\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/validation\/\">Validation<\/a>\n<\/li>\n\t\t\t<\/ul>\n\n\t\t\t<\/section>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>FDA QSR vs. QMSR: What Medical Device Manufacturers That DO NOT Have ISO 13485 Need to Know Short answer:\u00a0No. Longer answer:\u00a0From a high-level perspective, the standards now differ in intent, content, and structure. \u00a0 A high-level look at the alignment between ISO 9001:2015 and ISO 13485:2016 \u00a0 Intent:\u00a0Not fully aligned The standards share one ultimate [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3827,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[4],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v21.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.orielstat.com\/blog\/alignment-of-iso-9001-2015-and-iso-13485-2016\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"FDA QSR vs. QMSR: What Medical Device Manufacturers That DO NOT Have ISO 13485 Need to Know Short answer:\u00a0No. Longer answer:\u00a0From a high-level perspective, the standards now differ in intent, content, and structure. \u00a0 A high-level look at the alignment between ISO 9001:2015 and ISO 13485:2016 \u00a0 Intent:\u00a0Not fully aligned The standards share one ultimate [&hellip;]\" \/>\r\n<meta property=\"og:url\" content=\"https:\/\/www.orielstat.com\/blog\/alignment-of-iso-9001-2015-and-iso-13485-2016\/\" \/>\r\n<meta property=\"og:site_name\" content=\"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog\" \/>\r\n<meta property=\"article:published_time\" content=\"2024-01-10T04:06:33+00:00\" \/>\r\n<meta property=\"article:modified_time\" content=\"2024-01-11T16:50:07+00:00\" \/>\r\n<meta property=\"og:image\" content=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2021\/02\/Regulatory-Compliance-.jpg\" \/>\r\n\t<meta property=\"og:image:width\" content=\"2475\" \/>\r\n\t<meta property=\"og:image:height\" content=\"1856\" \/>\r\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\r\n<meta name=\"author\" content=\"usr192162\" \/>\r\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\r\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"usr192162\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\r\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.orielstat.com\/blog\/alignment-of-iso-9001-2015-and-iso-13485-2016\/","og_locale":"en_US","og_type":"article","og_description":"FDA QSR vs. QMSR: What Medical Device Manufacturers That DO NOT Have ISO 13485 Need to Know Short answer:\u00a0No. Longer answer:\u00a0From a high-level perspective, the standards now differ in intent, content, and structure. \u00a0 A high-level look at the alignment between ISO 9001:2015 and ISO 13485:2016 \u00a0 Intent:\u00a0Not fully aligned The standards share one ultimate [&hellip;]","og_url":"https:\/\/www.orielstat.com\/blog\/alignment-of-iso-9001-2015-and-iso-13485-2016\/","og_site_name":"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog","article_published_time":"2024-01-10T04:06:33+00:00","article_modified_time":"2024-01-11T16:50:07+00:00","og_image":[{"width":2475,"height":1856,"url":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2021\/02\/Regulatory-Compliance-.jpg","type":"image\/jpeg"}],"author":"usr192162","twitter_card":"summary_large_image","twitter_misc":{"Written by":"usr192162","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.orielstat.com\/blog\/alignment-of-iso-9001-2015-and-iso-13485-2016\/#article","isPartOf":{"@id":"https:\/\/www.orielstat.com\/blog\/alignment-of-iso-9001-2015-and-iso-13485-2016\/"},"author":{"name":"usr192162","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/a775f07c9602a3521143e80692594553"},"headline":"ISO 13485:2016 and ISO 9001:2015: Are They Aligned?","datePublished":"2024-01-10T04:06:33+00:00","dateModified":"2024-01-11T16:50:07+00:00","mainEntityOfPage":{"@id":"https:\/\/www.orielstat.com\/blog\/alignment-of-iso-9001-2015-and-iso-13485-2016\/"},"wordCount":489,"publisher":{"@id":"https:\/\/www.orielstat.com\/blog\/#organization"},"articleSection":["ISO 13485 QMS Compliance"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.orielstat.com\/blog\/alignment-of-iso-9001-2015-and-iso-13485-2016\/","url":"https:\/\/www.orielstat.com\/blog\/alignment-of-iso-9001-2015-and-iso-13485-2016\/","name":"","isPartOf":{"@id":"https:\/\/www.orielstat.com\/blog\/#website"},"datePublished":"2024-01-10T04:06:33+00:00","dateModified":"2024-01-11T16:50:07+00:00","inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.orielstat.com\/blog\/alignment-of-iso-9001-2015-and-iso-13485-2016\/"]}]},{"@type":"WebSite","@id":"https:\/\/www.orielstat.com\/blog\/#website","url":"https:\/\/www.orielstat.com\/blog\/","name":"Oriel STAT A MATRIX Blog","description":"","publisher":{"@id":"https:\/\/www.orielstat.com\/blog\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.orielstat.com\/blog\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/www.orielstat.com\/blog\/#organization","name":"Oriel STAT A MATRIX Blog","url":"https:\/\/www.orielstat.com\/blog\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/logo\/image\/","url":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/OSAM-Eliquent-logo-color.png","contentUrl":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/OSAM-Eliquent-logo-color.png","width":1458,"height":1042,"caption":"Oriel STAT A MATRIX Blog"},"image":{"@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/a775f07c9602a3521143e80692594553","name":"usr192162","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/1412cb81dc66fbc000fb222b1ea52700?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/1412cb81dc66fbc000fb222b1ea52700?s=96&d=mm&r=g","caption":"usr192162"},"url":"https:\/\/www.orielstat.com\/blog\/author\/usr192162\/"}]}},"_links":{"self":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/7647"}],"collection":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/comments?post=7647"}],"version-history":[{"count":8,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/7647\/revisions"}],"predecessor-version":[{"id":7987,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/7647\/revisions\/7987"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/media\/3827"}],"wp:attachment":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/media?parent=7647"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/categories?post=7647"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/tags?post=7647"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}